Focused Ultrasound Foundation Support of Medicare Coverage Pathway


Key Points

  • A new pathway proposed by the Centers for Medicare & Medicaid Services (CMS), Transitional Coverage for Emerging Technologies (TCET), would allow some qualifying breakthrough medical devices to secure Medicare reimbursement. 
  • The Foundation has submitted a letter in support of the TCET pathway.  

A new pathway proposed by the Centers for Medicare & Medicaid Services (CMS), Transitional Coverage for Emerging Technologies (TCET), would allow some qualifying breakthrough medical devices to secure Medicare reimbursement.  

Learn More About the Proposed TCET Pathway 

The Foundation recently submitted the following letter in support of the TCET Pathway: 

August 28, 2023

Dear Administrator Brooks-LaSure:  

We appreciate the opportunity to offer the following comments on the proposed TCET program.  

We offer views from the perspective of a 501(c)(3) medical technology research, education and advocacy organization dedicated to advancing the development and clinical adoption of focused ultrasound, a noninvasive therapeutic medical device technology, for the treatment of a wide range of medical conditions. The Focused Ultrasound Foundation was founded in 2006 to accelerate the development and adoption of focused ultrasound to improve the lives of countless individuals with serious medical disorders. Patients are always central to our mission, and we aim to bring focused ultrasound treatments to patients as quickly as possible because we have seen the great impact these treatments can have on the lives of so many.  

One of the most critical factors limiting widespread and equitable patient access to focused ultrasound therapies, and other highly innovative medical device technologies, is the years of lag time between FDA clearance and coverage and reimbursement. For Medicare beneficiaries, it is often surprising that a therapy would be deemed safe and effective by the FDA yet not available for them due to lack of CMS coverage. Without coverage and reimbursement, clinicians may be unable to offer innovative treatments like focused ultrasound to their patients, despite clinical evidence demonstrating that the treatment could be less invasive, with less risk of complications, and could offer an improved quality of life as compared to other standard treatments. 

In a previously finalized rule, CMS created a Medicare coverage pathway that would grant automatic Medicare coverage to devices deemed “breakthrough” by the FDA, immediately upon their FDA marketing authorization. This coverage would extend for four years, during which time the manufacturer would be able to collect additional evidence required for a long-term coverage policy.  

The FUSF expressed support for the MCIT program as it would eliminate the gap between FDA clearance and Medicare coverage for innovative medical devices, providing more certainty to manufacturers, more tools in clinicians’ armamentarium to treat disease, and more universal and equitable treatment options for patients. We were disappointed in the repeal of the MCIT program. 

While we believe the TCET proposal is a step in the right direction, we feel that the limited scope of the program will not support the breadth of innovative products as they come to market, and patients will continue to wait too long or be required to pay out of pocket for many new treatments like focused ultrasound. We know that CMS is committed to helping patients, reducing suffering, improving outcomes, and saving lives, and we are hopeful that the finalized TCET program will close the current gap between FDA clearance and Medicare coverage.  

We encourage CMS to consider the following when finalizing the TCET program.  

Expand Eligibility  

CMS is proposing the following TCET eligibility criteria:  

  • FDA-designated Breakthrough Devices,  
  • Determined to be within a Medicare benefit category,  
  • Not already the subject of an existing Medicare NCD, and  
  • Not otherwise excluded from coverage through law or regulation.  

These narrow criteria will undoubtedly limit the devices that qualify, and many innovative treatments would still languish after FDA clearance. 

As proposed, only devices that have received breakthrough designation by the FDA would be eligible for the TCET program. While only a small number of devices have received breakthrough marketing authorization by the FDA, there are many other promising innovative devices that may not meet the stringent definitions for breakthrough (e.g. for a serious medical condition that does not meet the threshold for life-threatening or debilitating) or were approved before the implementation of the Breakthrough pathway yet still lack CMS coverage. We urge CMS to expand the criteria for acceptance to the TCET program to include more universal coverage of noninvasive medical devices including focused ultrasound that may be strongly preferred by patients as compared to more invasive alternatives. We encourage CMS to consider “patient preference” as an optional criterion to support acceptance into the TCET program. 

Additionally, we encourage the coverage of off-label use of devices accepted to the TCET program. For many innovative medical technologies such as focused ultrasound, a single device could have several clinical applications. For example, a prostate-specific device could be effective treating both prostate cancer and benign prostatic hyperplasia. FDA labeling of the device in this case is often more generic – i.e. prostate tissue ablation. Such a general label may  

not meet the strict requirements for breakthrough despite having a similar or greater impact on the lives of patients as other breakthrough devices. In a case such as this, we propose that the TCET program should provide coverage for an off-label indication (e.g. prostate cancer) that meets the breakthrough designation criteria provided there is clinical evidence to support its safety and efficacy. 

Expand Capacity  

In the TCET proposal, CMS anticipates the program only handling a limited number of products per year (~ maximum of five). This low number is unlikely to capture the breadth of innovative medical device therapies in development, and Medicare patients will still be required to wait an unnecessarily long time before receiving access to many FDA-cleared therapies.  

Expand Scope  

Coding and payment should also be considered in the implementation of the finalized TCET rule. It is preferable that coding and payment be linked to coverage for devices within the TCET program. Many medical treatments obtain CMS coverage yet still are limited by low reimbursement rates and/or lack an appropriate code. Widespread adoption of innovative medical device therapies requires adequate coding, coverage, and reimbursement. Without all three components in place at the start of the provisional coverage window, the TCET program may not have its full intended effect for all breakthrough devices.  

Thank you for your consideration. We strongly urge CMS to continue to work with medical technology innovators, healthcare providers, patients, and others to improve and expedite the path from FDA marketing authorization to CMS coverage. Patients deserve more timely and equitable access to breakthrough treatments.  

If you have questions, please do not hesitate to contact me at or 202.886.5300.  


Jessica Foley, PhD  
Focused Ultrasound Foundation